DeviceClearance

Product code KHO— Clinical Chemistry

A FLUOROMETER

Classification name
Fluorometer, For Clinical Use
Device class
Class 1
Regulation
21 CFR 862.2560
Advisory panel
Clinical Chemistry
Total cleared
38
First cleared
Most recent

Market context for product code KHO

FDA has cleared 38 devices under product code KHO between 1976 and 2012, filed by 28 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code KHO

Adverse events under product code KHO

product code KHO
Malfunction
1,339
Total
1,339

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code KHO

Data sourced from openFDA. This site is unofficial and independent of the FDA.